PDF - 2 Mo

publicité
VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 Company & Technology Overview July, 2013 www.vaxeal-­‐group.com VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW OVERVIEW v  SME founded in 2009 -­‐ Headquartered in Vevey (CH) + Affiliates in France (R&D) and China v  Development of novel generaZon of Long Synthe7c Pep7de-­‐based therapeu7c vaccines in combinaZon with immunomodulatory drugs v  Focus on large market opportuniZes with MAJOR global paZent unmet medical needs: 1)  Cancer: Survivin, Midkine and CBX-­‐1 2)  Infec)ous diseases: HepaZZs C genotype 1 – 6 v  Strong IP Posi7on : 4 licensed patents + 2 pending patents v  Seed Investment: 3 million € + Founders money + 15 years academic investment v  Strategic Academic Partners 2 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW EXECUTIVE TEAM Dr Ahmed Bouzidi, PhD, MBA – CEO SCIENTIFIC ASSOCIATES Pr Eric Tartour, MD, PhD – Immuno-­‐Oncology -­‐  Successful entrepreneur in Europe and China -­‐  Board member of EBE-­‐Biopharma -­‐  Member of the R&D Task Force of Vaccines Europe -­‐  Director of the cancer immunomonitoring department of HEGP (Paris) -­‐  Director of an Inserm team dedicated to cancer immunotherapy -­‐  Clinical development of several cancer immunotherapies Mr Serge Grisard, Msc, MBA, EVP Corporate Development Pr Pedro Romero, MD, PhD – Immuno-­‐Oncology -­‐  18 years experience in Healthcare product development, CommercializaZon and PPPs -­‐  Global management at Siemens Medical, Pfizer, Astra-­‐Zeneca, and a range of private start-­‐ups Pr Giampietro Corradin, PhD – CTO -­‐  Worldwide expert in LSP-­‐based vaccines (30 years experience) -­‐  Development of several vaccine candidates Dr Jérôme Kerzerho, PhD – Director R&D -­‐  Expert in immunology -­‐  Discovered the tumor anZgens Midkine -­‐  IdenZfied new clinically relevant T cell epitopes in Survivin and Midkine tumor anZgens -­‐  Wordlwide Oncology expert at Ludwig insZtute -­‐  ElucidaZon of the immunological mechanisms of cancer therapeuZc vaccines -­‐  Laureate of the Robert-­‐Wenner award in 2001 (best Swiss researcher) Dr Bernard Maillère, PhD, Eng. – Immunology -­‐  Director of the department of immunochemistry of cellular immune response at the CEA (FR) -­‐  Developed the PredicZve plahorm of Vaxeal Pr François Sper7ni, MD, PhD – Virology -­‐  Expert in vaccine clinical development -­‐  Focused on the development of novel vaccine strategies in the field of hepaZZs C, tuberculosis, Malaria and allergy 3 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW ADVANCED PROPRIETARY TECHNOLOGY PLATFORMS FOR… IMMUNOGENICITY PREDICTION &
T CELL EPITOPE IDENTIFICATION PRODUCTION /
FORMULATION/
COMBINATIONS ü  A rapid idenZficaZon of relevant T cell epitopes to be incorporated in a vaccine ü  The design, formulaZon and validaZon of the vaccine candidates ü  Pre-­‐clinical proof of concept studies PRE-­‐CLINICAL VALIDATION IMMUNO-­‐MONITORING OF CLINICAL TRIALS ü  The evaluaZon of synergisZc combinaZon of the formulated vaccines with immunomodulatory agents ü  The immunomonitoring of clinical trials VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL -­‐ PIPELINE PRODUCT(
(
Survivin((
(SVX01)!(1)(
LEAD(
OPTIMIZATION(
INDICATION(
(
!
PRE0CLINICAL(
P0o0C(
Q1(2014!
!!
!!
Midkine(( NSCLC,(Colorectal,(Breast(
and(Ovarian(cancers(
(MDX01)!(2)(
Multiple(Cancers(
Combo((1+2+3)(
Multiple(Cancers(
(
!!
!!
!!
!!
(
!
Core/NS3(
Hepatitis(C(gen.1/6((
MARKET(
POTENTIAL(
PARTNERS(
!
Prostate,(Renal(and(
Pancreas(cancers,(
Metastatic(melanoma(
CBX01((3)(
PHASE(I(
(I/II)(
!
Q3(2014(
Q1(2015(
>(€5bn/(year!
INSERM(
0(
Ludwig!
>(€5bn/(year!
>(€5bn/(year!
!
>(€5bn/(year!
Q3(2016(
!
!
Q1(2014!
!
CMC!
!
!
!
>(€5bn/(year!
!
5 VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 ONCOLOGY PROGRAM VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW MAIN ISSUES IN TRADITIONAL CANCER VACCINE-­‐BASED APPROACHES Difficulty in achieving the right balance of CD4+ and CD8+ T cells -­‐ Short pepZdes-­‐, Weak Immunogenicity ü  As vaccine target of self or dispensable anZgens ü  Short pepZde based-­‐vaccines induce T cell anergy as they are presented by non APC protein-­‐ and DNA-­‐based vaccines mainly induce either CD4+ or CD8+ T cells TRADITIONAL)CANCER)VACCINE))
(Short'Pep+des.,'Recombinant'Proteins.'&'
Vector'Delivery.based'Vaccines)'
Restricted efficacy to certain ++)
cancer indicaZons or paZents HLA types Vaccine>mediated)
immunosupression)
Tumor-­‐mediated immunosupressive mechanisms ü  Treg inducZon ü  Overexpression of cosZmulatory inhibitory molecules (PD-­‐L1…) ü  Tumor-­‐mediated angiogenesis +/>)
Tumor)–)induced)
Tolerance)
Safety and Cost of Vaccines created from living organisms Tumor)
Immunosurveillance)
Impaired)an+tumoral)
immune)responses)
Limited longevity of the elicited an7-­‐tumoral responses leading to impaired protecZon against tumor relapses Need to op7mize tradi7onal therapeu7c cancer vaccine design to increase their clinical efficacy 7 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL -­‐ BREAKTHROUGH STRATEGY OF THERAPEUTIC CANCER VACCINE Vaxeal developed an innova7ve combined strategy of cancer vaccine enabling to overcome the limitaZons to current vaccine approaches COMPONENTS)OF)VAXEAL’S)CANCER)
THERAPEUTIC)VACCINES)
Long)Synthetic)Peptides)(LSP)Dbased)vaccine!
encompassing:!
! Multiple!promiscuous!CD4+!and!CD8+!T!
epitopes!!
! Derived!from!broadly!overexpressed!tumor!
antigens!playing!vital!functions!
ADVANTAGES)
Generate)longDterm)and)high)affinity)CD4+)and)CD8+)antiDtumoral)T)cell)
responses!in!all!of!the!cancer!patients!irrespective!of!their!HLA!types!
Limit)tumor)immune)escape!thanks!to!the!tumor!restricted!expression!
profile!and!vital!functions!of!the!tumor!antigen!target!
Optimized)formulation)with!potent)clinicalD
approved)immuneDadjuvant!
Improve)the)polarization)and)longevity!of!the!induce!T!cell!responses!
Synergistic)combination)with)clinicalDapproved)
advanced)immunomodulatory)drugs)
Overcome)tumourDmediated)immunosuppression)
! Low!doses!chemotherapy!
! AntiDangiogenic!drugs!!>#For#hypervascular#tumors!
! Others!advanced!immunomodulatory!drugs!
!
!
8 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL CANCER VACCINE -­‐ COMPETITIVE ADVANTAGES Short&Pep,des&
Recombinant&
Proteins&
Vector&delivery&
(e.g.%DNA%plasmide,%
viral%vector,..)%
★★★%
7%
★★%
★★★%
★★★%
★★★%
★%
★★%
★★★%
Applicability&a&broad&target&
popula,on/cancers&
★ ★ ★%
★★%
7%
★★%
★★%
Induc,on&of&longBlas,ng&
protec,on&against&relapse&
★ ★ ★%
★★ %
★%
★ ★%
★★ %
Overcome&of&tumorBinduced&
immunosuppressive&
mechanisms&(T&cell&exhaus,on)&
★★★%
7%
7%
7%
7%
Safety&
★★★%
★★★%
★★★%
★★%
★%
Ease&of&produc,on&and&
purifica,on&
★★★%
★★★%
★★★%
★%
★%
Stability&
★★★%
★★★%
★★★%
Protein&dependent&
Vector&dependent&
Clinical&efficacy&
★ ★ ★%
★★%
7%
★%
★★%
Vaxeal&Therapeu,c&
Vaccines&
LSPs&
Immunogenicity&
★★★%
Specificity&
-­‐ Nul, ★ Poor, ★★ Moderate, ★★★ OpZmal 9 VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 THANK YOU
For more information…
Website: www.vaxeal-­‐group.com Contact: [email protected] 
Téléchargement
Explore flashcards